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TubeClear Control Box Model 101

by Actuated Medical, Inc.

TubeClear Control Box Model 101 (101-US) is a Class II device made by Actuated Medical, Inc., cleared under FDA 510(k) K163092 on 30 Nov 2016 (1 earlier submission) and listed in FDA GUDID since 8 Sep 2016 (UDI-DI 00850458007010), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163092 Date30 Nov 2016DecidedStatusActive
United StatesGUDID listing Number00850458007010 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163092 decided 30 Nov 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00850458007010 listed 8 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131052
  2. Listed FDA GUDID 00850458007010
  3. Cleared FDA 510(k) K163092

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TubeClear
Generic name
Enteral feeding/decompression tube clearing stem
Model / Ref / Catalog
Control Box Model 101, 101-US
Primary DI / UDI-DI
00850458007010
510(k) Number
FDA product code
FPD, KNT
GMDN term
Enteral feeding/decompression tube clearing stem
Device class
Class II
Regulation number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Category: Enteral feeding/decompression tube clearing stemEnteral feeding/decompression tube clearing actuator

Cleared under the same submission (K131052)

and 8 more cleared under K131052

Cleared under the same submission (K163092)

Similar devices

Also classified as Enteral feeding/decompression tube clearing actuator.

Similar devices

Other devices filed under FDA product code FPD (Tube, Feeding).

Other devices from Actuated Medical, Inc.

See all devices from Actuated Medical, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)